Apparatus and methods for treating sleep apnea

ABSTRACT

An apparatus and method for treating sleep apnea and/or snoring is provided. The apparatus includes an appliance sized and structured to be placed in the pharyngeal region of a human or animal and being effective in treating sleep apnea and/or snoring, for example in maintaining openness of an oropharyngeal region of a human or animal during natural sleep, advantageously while not interfering with normal functioning of the epiglottis. Preferably, the appliance is non-circumferential in form and includes rounded, spaced apart end portions.

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. provisionalapplication No. 60/436,945 filed on Dec. 30, 2002, and U.S. provisionalapplication No. 60/437,058 filed on Dec. 30, 2002, the entiredisclosures of which are incorporated herein by this specific reference.

BACKGROUND OF THE INVENTION

[0002] The present invention generally relates to apparatus and methodsfor treating sleep apnea and/or related breathing disorders, and morespecifically relates to apparatus for placement in the oropharyngealregion of a human or animal and methods using such apparatus fortreating sleep apnea and/or snoring.

[0003] Sleep apnea is a sleep-related breathing disorder that is thoughtto affect between 1-10% of the adult population. Recent epidemiologicdata indicate that 2% of women and 4% of men between the ages of 30 and60 years meet the minimum diagnostic criteria for sleep apnea syndrome,representing more than 10 million individuals in the United States. Itis a disorder with significant morbidity and mortality, contributing toincreased risk of hypertension, cardiac arrhythmias, stroke, andcardiovascular death. Another common sleep-related breathing disorder issnoring, which may be associated with or independent of sleep apnea.

[0004] The present invention has been developed to aid in the treatmentof snoring and/or the various degrees of hypopnea and apnea that occurdue to pathological disturbances in the sleep process. One of the mainreasons of the sleep disturbance is the relaxation of the tongue andpharyngeal walls to varying degrees during the several stages of sleep.When fully awake, these tissues have normal tone as air passes in andout of the lungs during respiration. However, during sleep, themusculature supporting these tissues relaxes. As air is inspired, thetongue and posterior walls of the pharynx collapse, causing snoring ormore seriously, causing partial or complete obstruction of the airway.

[0005] Obstructive sleep apnea occurs due to a collapse of soft tissuewithin the upper airway during sleep. The ongoing force of inspirationserves to generate increasingly negative pressure within the pharynx,causing further collapse. The lack of respiration results in inadequateblood oxygenation, and rising carbon dioxide levels. The cardiovascularresponse produces an increase in the blood pressure and pulse. Cardiacarrhythmias often occur. The carbon dioxide increase and oxygendesaturation triggers a transition to a lighter sleep stage, usuallywithout wakefulness. This transition brings a return to tonicity of themuscles of the upper airway, allowing normal breathing to resume. Theperson then returns to deeper stages of sleep and the process isrepeated. The disease is quantified in terms of respiratory disturbancesper hour. Mild disease begins at ten per hour, and it is not uncommon tofind patients with indices of about one hundred or more.

[0006] Not surprisingly, sleep is extremely fragmented and of poorquality in persons suffering from sleep apnea. As a result, such personstypically feel tired upon wakening and may fall asleep at inappropriatetimes during the day. All aspects of quality of life, from physical andemotional health, to social functioning are impaired by obstructivesleep apnea.

[0007] Continuous Positive Airway Pressure (“CPAP”), disclosed forexample in U.S. Pat. No. 5,065,756, is a popular non-surgical treatmentfor patients suffering from sleep apnea. The disclosure of this patentis incorporated in its entirety herein by reference. CPAP isadministered by means of a mechanical unit that delivers pressurizedroom air to the nasal passage, or airway, through a nose mask that isworn by the patient during sleep. Pressurized air enters from the CPAPunit through the nose when a person is sleeping, and opens the airwayfrom the inside almost as if the air were an internal splint. Thecorrect pressure for the individual is determined in a sleep laboratory.If the nasal airway will admit the flow of air, CPAP has in many casesoffered immediate relief. Unfortunately however, compliance with, andlong-term acceptance of this treatment are generally poor. Studies haveshown that between 20% and 50% of patients fail to use nasal CPAP asprescribed. Problems associated with CPAP include excessive dryness ofthe mouth and throat, mucous congestion, sinusitis, and rhinorrhea.Breathing against positive air pressure is also discomforting to manypatients.

[0008] Other non-surgical treatments for sleep apnea include the use oftongue retaining devices and other oral appliances that hold and/or pullthe tongue or jaw in a forward position to open the airway by reducingcollapse of the soft palate and/or tongue. These devices also sufferfrom poor compliance rates, and are usually associated with degenerativechanges in the temporomandibular joint.

[0009] Surgical procedures have been proposed and practiced for thetreatment of moderate to severe sleep apnea. Uvulopalatopharyngoplasty(“UPPP”) is a surgical procedure used to treat obstructive sleep apnea.In UPPP, any remaining tonsillar tissue and a portion of soft palate isremoved. The procedure increases the width of the airway at the throatopening. However, UPPP does not address apnea caused by obstructionsdeeper in the throat and airway, for example, apnea resulting fromcollapse of tissue near the base of tongue or in the oropharyngealregion of the airway.

[0010] LAUP, or Laser-Assisted Uvulopalatoplasty, is a modification ofthe above-mentioned technique, but has not proven particularly usefulfor sleep apnea. These surgical techniques are extremely invasive,requiring general anesthesia, and a prolonged, painful recovery.

[0011] Radio frequency tissue ablation (RFTA) with the trade name“Somnoplasty”, has been used to shrink the soft palate, uvula and reducetongue volume in the treatment of snoring and obstructive sleep apnea.Somnoplasty utilizes a radiofrequency tool that generates heat to createcoagulative lesions at specific locations within the upper airway. Thelesions created by the procedure are naturally resorbed in approximatelythree to eight weeks, reducing excess tissue volume and increasing theairway opening. Like UPPP and LAUP, more than one session is typicallyrequired and it does not address sleep apnea resulting from tissuesdeeper in the throat than the upper airway.

[0012] Another area of surgical interest lies in techniques designed topull the tongue anteriorly. The most recent such surgical systemdesigned to treat snoring (as well as obstructive sleep apnea) wasapproved by the FDA in February 1998. Known as the tongue suspensionprocedure (with the trade name Repose), it is intended to pull thetongue forward, thereby keeping the tongue from falling into the airwayduring sleep. The system utilizes a bone screw inserted into themandible. The screw attaches to a non-absorbable suture which travelsthe length of the tongue and back. Similarly, the hyoid bone can bedrawn anteriorly with two distinct screws, also attached to themandible.

[0013] Techniques have also been developed for treating, specifically,the condition of snoring. Conrad et al., U.S. Pat. No. 6,250,307discloses a method for treating snoring of a patient, which includesembedding an implant into a soft palate of a patient in order to alter adynamic response of a soft palate to airflow. The methods of Conrad etal. are specifically designed to reduce the audibility of snoring but donot address the more serious condition of sleep apnea.

[0014] These conventional devices and treatments continue to suffer poorcure rates. The failures lie in their inability to maintain patency inthe retropalatal region and retroglossal region (the caudal margin ofthe soft palate to the base of the epiglottis). The poor success ratescombined with high morbidity, contribute to an ongoing need for moreeffective treatments for sleep apnea and/or snoring.

SUMMARY OF THE INVENTION

[0015] Accordingly, the present invention provides apparatus and methodseffective to treat, for example, to substantially eliminate or at leastreduce the occurrence of, sleep apnea and/or snoring, meaning to includesnoring and/or other sleep-related breathing disorders. The apparatusand methods are relatively straightforward to structure and use, areminimally invasive and provide substantial benefits over conventionaltechniques in controlling sleep apnea and/or snoring.

[0016] In one broad aspect, the present invention provides apparatuscomprising an appliance sized and structured to be permanently (that is,for long term usage or for a relatively long time, such as at leastabout 1 week or about 1 month, preferably at least about 6 months, morepreferably at least about 1 year, even more preferably about 5 years orlonger) or temporarily implanted or placed in an oropharyngeal region ofa human or animal.

[0017] The present apparatus may comprise any material or materialssuitable for placement in the pharyngeal region which are effective tostiffen, reinforce and/or strengthen tissues of the region in order toprovide support to these tissues against collapse such that a patientcan breathe more effectively than the patient would breathe without thematerial or materials placed in the region.

[0018] In one embodiment of the invention, the apparatus generallycomprise an appliance sized and structured to be placed in a givenposition in the oropharyngeal region, other than to facilitate asurgical procedure, and to be effective, when placed in the givenposition, to treat sleep apnea and/or snoring in a human and or animal(hereinafter, sometimes “patient”). In addition, the appliance isstructured to be effective, when so placed, to provide at least oneadditional benefit relative to a different device that is sized andstructured for placement in a position in the patient other than in thegiven position in the oropharyngeal region. Preferably, the appliance isstructured to provide an enhanced compliance with normal, healthyfunctioning of the oropharyngeal region of a patient relative to such adifferent device, for example, a stent that is not specificallystructured to be utilized for treatment of sleep apnea. For example, theapparatus is structured to have an enhanced, relative to such adifferent device, ability to be tolerated, preferably comfortablytolerated, by the human or animal while the apparatus is in the givenposition in the oropharyngeal region, such as when the human or animalis awake or is naturally sleeping.

[0019] The appliance of the present invention is advantageouslystructured to have an enhanced, relative to such a different device,ability to provide support against collapse of the oropharyngeal regionduring natural sleep, as well as to allow proper closure of an airway inthe oropharyngeal region during swallowing.

[0020] Preferably, the appliance is sized and structured so that, whenso placed in the given position in the oropharyngeal region, theappliance is located substantially entirely within the pharyngeal regionincluding, preferably, the oropharyngeal region. The apparatus is sizedand structured to be temporarily placed in the given position or to beplaced in the given position on a relatively long term basis forexample, as described elsewhere herein. In addition, the appliance ispreferably structured to resist migration within the oropharyngealregion or outside the oropharyngeal region.

[0021] In one embodiment of the invention, the appliance comprises asubstantially flat or planar member, when located outside the body in aresting or at rest position, including spaced apart end portions and abody portion joining the end portions. In this embodiment of theinvention, the apparatus preferably is designed such that when theapparatus is appropriately positioned in the given position, theappliance takes on a curved configuration with end portions bearingagainst and supporting against collapse, the lateral walls of theoropharyngeal region. The appliance may be sized and structured suchthat when the apparatus is appropriately placed in the given position,the end portions are spaced apart anteriorly of the posterior wall ofthe oropharyngeal region, for example, by a portion of the anterior wallof the oropharyngeal region. Preferably, the appliance expands to forman effective diameter of about 32 mm or greater in order to adequatelyexpand to fill the oropharyngeal region

[0022] Advantageously, the apparatus is structured to facilitate removalthereof from the oropharyngeal region. For example, the apparatus may bestructured such that when the apparatus is in other than the deployedconfiguration, for example, when the apparatus is located outside anoropharyngeal region of a human or animal or outside the body of thehuman or animal in a resting position, the appliance comprises a memberthat has a flexibility and resiliency that allows the appliance to befolded, rolled or coiled to take on a relatively smaller radius forfacilitating insertion thereof into the oropharyngeal region, forexample, through the mouth or oral cavity of the patient. When releasedinto the pharyngeal region, the appliance unfolds, unrolls or uncoils,and provides pressure against one or more portions of the pharyngealregion, providing support thereto and maintaining or achieving patencyof the pharyngeal region, for example, whether the patient is awake oris naturally sleeping.

[0023] The appliance is preferably sized and structured to allowsubstantially natural functioning of the oropharyngeal region and theepiglottis when the appliance is located in the given position in thepharyngeal region of the patient.

[0024] It will become apparent that various configurations of theapparatus are possible to achieve one or more of the benefits of thepresent invention in treating, e.g. controlling, sleep apnea and/orsnoring, and it is to be appreciated that each of such variousconfigurations, for example, the herein disclosed various configurationsand modifications thereof, are considered to be within the scope of thepresent invention. Such configurations include, but are not limited to,an appliance having a substantially elliptical configuration, asubstantially circular configuration, a substantially rectangularconfiguration, a substantially cylindrical configuration, asubstantially linear configuration, a substantially cross-shapedconfiguration, a substantially C-shaped configuration, a substantiallycuff shaped configuration, a substantially coil shaped configuration andthe like configurations and combinations thereof. For example, in a morespecific embodiment of the invention, the appliance comprises, in a restposition outside the body of a human or animal a substantially flat,flexible, elliptical member having rounded end portions, a lengthdefined between the end portions, and a body portion comprising aplurality of spaced apart struts extending along at least a substantialportion of the length between the end portions.

[0025] Preferably, in all embodiments of the invention, the appliance,when located in the oropharyngeal region, has a resiliency andflexibility, for example, resiliency and/or flexibility in at least onedirection or at least two different directions or at least threedifferent directions, that enables the appliance to provide anappropriate amount of support and reinforcement to oropharyngeal tissuesduring natural sleep, while enabling substantially normal functioning ofthe oropharyngeal region and the epiglottis, for example, duringswallowing.

[0026] The appliance preferably comprises an elastic material. Morepreferably, the appliance comprises a super-elastic material. A numberof suitable elastic and super-elastic materials are well known and canbe employed in the present apparatus. One particularly useful materialis a nickel titanium alloy, known as Nitinol. The appliance preferablyhas a hoop strength effective to support the oropharyngeal regionagainst collapse during natural sleep. More preferably, the appliancehas a hoop strength in a range of at least about 5 cm water to about 400cm water or greater.

[0027] The apparatus advantageously comprises an appliance sized andstructured to be placed in a position in the oropharyngeal region inproximity to the epiglottis, other than to facilitate a surgicalprocedure, effective in treating sleep apnea and/or snoring. Theappliance is sized and structured to substantially entirely fit withinthe oropharyngeal region when placed in position. A portion of thedevice may also be considered to extend above the oropharyngeal regionalong the posterior portion of the pharynx.

[0028] In another broad aspect of the invention, the apparatus fortreating sleep apnea and/or snoring comprises an element placed withinthe oropharyngeal region that is effective, when so placed, to stiffen,reinforce and/or strengthen tissues within the oropharyngeal region inorder to support these tissues against collapse and allow substantiallynormal breathing during sleep.

[0029] For example, the element may comprise at least one strip ofmaterial that is structured to be placed within the walls of thepharyngeal region. For example, the element may comprise multiple stripsof material that are structured and suitable to be implanted within theoropharyngeal tissues, for example, beneath the mucosal tissue, forexample, in a spaced apart, substantially horizontal fashion.

[0030] In a related aspect of the invention, a method for treating sleepapnea and/or snoring comprises the steps of securing one or moreelements to the pharyngeal region and allowing the elements to providean opening force against the pharyngeal walls, such opening force beingsufficient to reinforce the walls against collapse during natural sleepwhile allowing substantially normal functioning of the oropharyngealregion.

[0031] Preferably the method comprises placing at least partiallysubmucosally, within the pharyngeal region of a patient, an applianceeffective, when so placed, to maintain patency of the pharyngeal region.

[0032] Preferably, the step of placing comprises placing the apparatussubstantially entirely submucosally, preferably in the oropharyngealregion.

[0033] The apparatus, in accordance with an especially advantageousembodiment of the invention, is sized to be placed, at least partially,circumscribing an interior hollow passage defined by the pharyngealregion, for example the oropharyngeal region. In a related aspect of theinvention, the appliance is sized to be placed circumscribing, at leastonce, the interior hollow passage defined by the pharyngeal region.

[0034] In another embodiment of the invention, the element may comprisean element that provides a magnetic opening force against collapsingpharyngeal, for example, oropharyngeal, tissues. For example, theelement may comprise an appliance, such as described and shown elsewhereherein, that is at least partially magnetized. More specifically, theelement may comprise two or more magnetic elements having like polesfacing one another, to create a magnetic field that can be utilized toprovide a useful opening force to the pharyngeal, for example,oropharyngeal, region.

[0035] Methods for treating sleep apnea and/or snoring in a human or ananimal having an oropharyngeal region are provided. In one aspect of theinvention, the methods generally comprise providing an appliance, suchas described elsewhere herein, in the oropharyngeal region of the humanor animal. The appliance, located in the oropharyngeal region, iseffective in treating sleep apnea and/or snoring during natural sleep ofthe human or animal.

[0036] In one embodiment, the step of providing includes placing anappliance in the oropharyngeal region that is effective in maintainingpatency of the oropharyngeal region during natural sleep of the human oranimal. Preferably, the appliance is effective in maintaining patencywithout causing substantial interference with one or more naturalfunctions of the oropharyngeal region or the epiglottis. For example,the appliance may be structured, when placed in the pharyngeal region,to be effective to support the tissues of the oropharyngeal regionagainst collapse while allowing the oropharyngeal region to close and/orotherwise function consistent with normal swallowing. The apparatus isdesigned so that, when the appliance is placed in the pharyngeal regionit is effective in supporting and holding the lateral walls of theoropharyngeal region in an open position, and/or in supporting andholding the tongue of the patient in a forward position, for example,during natural sleep of the patient.

[0037] In yet another embodiment of the invention, a method is providedfor maintaining patency of a pharyngeal region of a human or an animalduring natural sleep. The method generally comprises the steps ofproviding a member in a substantially flat or precurved configuration,the member having a body portion and end portions spaced apart by thebody portions, and implanting the member, at least partiallysubmucosally, within the pharyngeal region.

[0038] Advantageously, the member is effective to provide asubstantially constant force against at least a portion of each of aright and left lateral wall of the pharyngeal region.

[0039] For example, the step of implanting comprises implanting themember into pharyngeal region such that the member is substantiallyentirely submucosally implanted therein.

[0040] In yet another related embodiment of the invention, a method formaintaining patency of a pharyngeal region of a human or animal duringnatural sleep and for purposes other than surgery is provided wherein,the method generally comprises the steps of causing a tissue reaction ofa pharyngeal region of the patient, said tissue reaction being effectivein at least one of strengthening and stiffening lateral walls of thepharyngeal region. For example, the step of causing a tissue reactionmay comprise applying an active agent to the walls of the pharyngealregion or, for example, placing at least one member into the lateralwalls.

[0041] Preferably, the step of providing may include inserting theappliance into the oropharyngeal region, for example through the mouthor oral cavity of the patient, or alternatively, through the nasalcavity of the patient, while the appliance is in a first configurationand, thereafter, allowing the appliance to reconfigure to a secondconfiguration within the oropharyngeal region.

[0042] In yet another aspect of the invention, a method for treatingsleep apnea and/or snoring comprises causing a tissue reaction in anoropharyngeal region of a patient. Such tissue reaction is effected tocause sufficient stiffening and/or strengthening of targetedoropharyngeal tissues in order to substantially reduce the occurrence ofcollapse of those tissues during natural sleep of the patient.

[0043] For example, the step of causing a tissue reaction may compriseone of injecting a suitable agent into the tissues, applying wave energyto the tissues and/or causing mechanical irritation to the tissues inorder to provoke a strengthening response.

[0044] Each and every feature described herein, and each and everycombination of two or more of such features, is included within thescope of the present invention provided that the features included insuch a combination are not mutually inconsistent.

[0045] These and other aspects of the present invention are apparent inthe following detailed description and claims, particularly whenconsidered in conjunction with the accompanying drawings in which likeparts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

[0046]FIG. 1 shows a side view of an apparatus of the present inventionpositioned in an oropharyngeal region of a patient (shown incross-section for clarity).

[0047]FIG. 2 shows a perspective view of an embodiment of the inventioncomprising a substantially solid walled cylindrical appliance.

[0048]FIG. 3 shows a perspective view of another embodiment of theinvention comprising a substantially mesh walled cylindrical appliance.

[0049]FIG. 4 shows a perspective view of an additional embodiment of theinvention similar to the apparatus shown in FIG. 2, and including arecessed portion for accommodating an epiglottis of a patient.

[0050]FIG. 5 shows a perspective view of yet another embodiment of theinvention including an extended portion.

[0051]FIG. 6 shows a perspective view of a further embodiment of theinvention comprising a coiled appliance.

[0052]FIGS. 7, 8 and 9 show, in perspective view, various otherembodiments of the invention comprising substantially cuff-shapedappliances of different proportions to accommodate different patientneeds.

[0053]FIG. 10 shows a perspective view of still another embodiment ofthe invention comprising a substantially cuff shaped embodimentcomprising a mesh material.

[0054]FIG. 11 a perspective view shows a yet further embodiment of theinvention comprising a substantially solid C-shaped appliance havingapertures for allowing tissue ingrowth.

[0055]FIG. 12 shows a perspective view of an alternate embodiment of theinvention that comprises a flat flexible member including spaced apartstruts extending between rounded end portions.

[0056] FIGS. 13-16 show, in plan view, other alternate embodiments ofthe invention similar to the embodiment shown in FIG. 12.

[0057] FIGS. 17-21 show, in plan view, various other alternativeembodiments of the invention comprising a single loop element.

[0058] FIGS. 22-23 show, in plan view, yet other embodiments of theinvention.

[0059]FIG. 24 shows a side view of a preferred embodiment of theinvention in which the apparatus comprises an elongated elementstructured to be at least partially submucosally implanted in thepharyngeal region of a patient.

[0060]FIG. 24a shows an alternative cross section of an embodiment ofthe invention similar to the embodiment shown in FIG. 24, comprisingmultiple, spaced apart elongated elements at least partiallysubmucosally implanted within the oropharyngeal region of a patient.

[0061]FIG. 25 shows a plan view of the embodiment of the invention shownin FIG. 24

[0062]FIGS. 25a and 25 b show cross-sectional views of alternativecross-sectional shapes of the embodiment of the invention shown in FIG.25.

[0063] FIGS. 26-28 each show a simplified view of the oropharyngealregion having various apparatus of the invention submucosally implantedtherein.

DETAILED DESCRIPTION OF THE INVENTION

[0064] In a broad aspect of the invention, the apparatus generallycomprise an appliance sized and structured to be placed in a givenposition in an oropharyngeal region of a human or animal patient, otherthan to facilitate a surgical procedure on said patient, and beingeffective in treating sleep apnea and/or snoring of said patient. Theappliance is further effective, when so placed in the given position, toprovide at least one additional benefit or advantage relative to adevice sized and structured for placement in a different position in ahuman or animal wherein a “different position” is defined as a positionother than the given position.

[0065] Incorporated herein by this specific reference is the entiredisclosure of each of the following patents:

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[0067] It has been discovered that a number of the devices disclosed inthe above referenced patents, that are conventionally utilized orsuggested for utilization in body regions other than the oropharyngealregion and/or to treat conditions other than sleep apnea and/or snoring,can be utilized or modified to be utilized in the oropharyngeal regionof a human or an animal in order to treat sleep apnea and/or snoring, inaccordance with the present invention. Any such modification ormodifications to such conventional devices are considered to be includedwithin the scope of the apparatus of the present invention. In addition,the use of any of such previous devices, and any modified such previousdevices, in the oropharyngeal region of a human or an animal in order totreat sleep apnea and/or snoring is considered to be within the scope ofthe methods of the present invention. It can be noted that currentlythere are no stents marketed which are designed to expand to diametersin excess of 32 mm

[0068] For example, the at least one additional benefit or advantage ofthe apparatus of the present invention, relative to a deviceconventionally utilized or suggested for utilization in body regionsother then the oropharyngeal region and/or to treat conditions otherthan sleep apnea and/or snoring, may comprise, without limitation, atleast one or more of the following: the apparatus is structured to belocated in the oropharyngeal region and to have an enhanced ability tobe tolerated by the human or animal, for example, while the human oranimal is awake or is naturally sleeping; the apparatus is structured toprovide enhanced resistance to static collapsing forces of theoropharyngeal region and/or hypopharynx; the apparatus is structured tohave an enhanced ability to allow for dynamic collapse; the apparatus isstructured to have enhanced non-mobility, for example, upon coughing,throat clearing and/or sneezing; the apparatus is structured to haveenhanced conformity to the healthy, normal shape of the pharynx; theapparatus is structured to have an enhanced ability to be removable; theapparatus is structured to have an enhanced ability to be deployableunder direct vision via nasopharyngoscopy/laryngoscopy; and the likebenefits.

[0069] In addition, the present apparatus preferably are structured tonot substantially interfere with swallowing, respiration, vocalization,mucociliary function, epiglottis functioning and the like. The presentapparatus are structured to maintain the openness of the pharyngealregion during natural sleep.

[0070] Turning now to FIG. 1, a cross-sectional anatomical view of ahuman patient 1 is shown. The patient 1 has apparatus 10 in accordancewith the present invention located within the patient's oropharyngealregion 1 a in order to treat, for example, control, reduce or eveneliminate, the occurrence of sleep apnea and/or snoring.

[0071] Snoring and sleep apnea are often caused by a combination ofnarrowness and low muscle tone of the upper airways. The tongue 2 afalls back and may obstruct the airway, possibly leading to an arousalreaction and disturbing the normal sleeping pattern. Other portions ofthe oropharyngeal region may also collapse. For example, the lateralwalls 2 b of the oropharyngeal region often become excessively lax andblock a free flow of air during respiration. When the patient 1 issupine, for example, when the patient 2 is asleep and lying on his/herback, the relaxed tongue 2 a moves inferior (down) and posterior (back),and/or the lateral walls 2 b of the oropharyngeal region collapseinwardly resulting in a narrower pharynx relative to when the patient 1is upright. One cause for the narrowing of the pharynx in the supineposition could be that the oropharyngeal region 1 a and hypopharyngealregion 1 b, which have low consistencies, collapse because of lack ofdirect hard tissue support.

[0072] The apparatus 10 may be secured to the pharyngeal region byvarious means. For example, the apparatus 10 may be sutured to thepharyngeal region, for example with dissolvable sutures that will allowthe apparatus 10 to be held in place while the apparatus 10 becomesfixed to the region by means of tissue ingrowth. Alternatively, theapparatus 10 may be secured to the region by means of a suitablebiocompatible adhesive as are presently known in the art. Alternativelystill, the apparatus 10 may be secured to the region by being surgicallyimplanted into the region, for example, directly beneath the region'smucosal layer, (hereinafter, “submucosally”), for example, by beingpulled, with a surgical needle for example, into and beneath the mucosallayer such that the apparatus at least partially circumscribes theregion.

[0073] The apparatus 10 of the present invention is preferably designedto provide direct support to at least some of these tissues when thepatient 1 is supine and asleep. For example, the apparatus 10 of thepresent invention is structured so that when placed in the givenposition in oropharyngeal region 1 a, the apparatus 10 will push thetongue forward, and/or push the lateral walls 2 b away from one anotherthereby holding the airway patent or open during the time the human oranimal is naturally sleeping.

[0074] As shown, the apparatus 10 may be sized and structured to bepositioned adjacent the epiglottis 2 c of patient 1, but preferably notin contact therewith. For example, in one embodiment of the invention,the apparatus 10 is designed to overlay a posterior wall 2 d of theoropharyngeal region 1 a and provide an opening force outwardly againstopposing lateral walls 2 b of the oropharyngeal region 1 a. In otherembodiments of the invention, the apparatus 10 is designed to restwithin a valecullar space 2 e and provide a pushing force against thebase 2 f of the tongue 2 a which makes up a portion of the anterior wall2 g of the oropharyngeal region 1 a. The valecullar space 2 e, as theterm is used herein, is defined as being the space between the anteriorwall 2 g of the throat and the upper tip 2 h of the epiglottis 2 c downto the conjunction of the epiglottis 2 c with the anterior wall 2 g ofthe pharynx.

[0075] In any event, the apparatus 10 is designed in such a manner as tosubstantially prevent same from interfering with the normal functioningof the tissue around the apparatus 10, particularly with the normalfunctioning of the epiglottis 2 c. The apparatus 10 may includestructures (described elsewhere herein) for anchoring or securing theapparatus 10 within the oropharyngeal region 1 a in order to prevent theapparatus 10 from migrating away from or out of the given position.

[0076] Preferably, in all embodiments of the invention, the apparatus 10is structured to closely and flexibly conform to the size and contoursof at least a portion of the oropharyngeal region 1 a.

[0077] In one useful embodiment, the apparatus 10 can be said to beeffective to provide a support substantially equivalent to the supportof tissue and/or muscles of an oropharyngeal region in a healthy, tonedstate.

[0078] As a specific example, the apparatus 10 may be sized and shapedto fit a human patient having a measured anterior-posterior lineardistance between the pharyngeal walls, when the patient is awake and notsupine, and the tongue and/or other tissues are not fully lax.

[0079] The apparatus 10 is preferably structured to maintain a radialforce or pressure, for example, a substantially constant radial force orpressure, against the oropharyngeal region, specifically against thelateral walls of the oropharyngeal region, the posterior portion of theoropharyngeal region, and/or the base of the tongue. The pressure of theapparatus maintained against this region is advantageously sufficient tomaintain patency of the oropharyngeal region during natural sleep in asupine position (for example, greater than about 10 cm of water), andpreferably exerts pressure less than that exerted by the surfaces of theoropharyngeal region during swallowing (for example, about 400 cm ofwater). The apparatus preferably has a hoop strength in a range of about5 cm water up to about 400 cm water. It is further noted that the designof apparatus 10 allows for variable hoop strength as measured alongdifferent points about the circumference of the appliance of theapparatus.

[0080] The present apparatus 10 is designed and structured to allowsubstantially normal functioning of the oropharyngeal and pharyngealregions, while maintaining the structural integrity of the apparatusover a long period of time. An important consideration in the design ofthe present apparatus 10 includes the requirement that the apparatus 10substantially maintain its structural integrity and strength despite thehighly dynamic, peristaltic motion of the oropharyngeal andhypopharyngeal regions.

[0081] For example, it is known that a human being typically swallows anaverage of two times a minute, throughout the day. This equals around2000 swallows per day. The force of the swallow varies from 1.5 lbs. to6 lbs. of pressure, and the force lasts for about 0.1 to about 0.2second.

[0082] Swallowing also includes the involuntary apposition of the softpalate to the posterior pharyngeal wall, which is believed to lastalmost a second and producing a pressure of about 160 millimeters ofmercury and initiates pharyngeal peristalsis, i.e. the wavelike muscularcontractions that move food along the alimentary canal in the pharyngealregion. This moving front of contraction passes through the pharyngealconstrictors in sequence, traversing the pharynx and hypopharynx atabout 15 centimeters per second to reach the upper esophageal sphincterin about one second. The hypopharyngeal contraction lasts about 0.3 toabout 0.5 second and generates an intraluminal pressure of 200millimeters of mercury. The present invention is designed to flex andcontract along with this wave-like motion of the various muscles in theoropharyngeal and hypopharyngeal region.

[0083] The appropriate amount of force necessary to provide adequatesupport to maintain patency and consistent air flow the oropharyngealregion during sleep, while allowing for the dynamic motion of thepharyngeal region and normal function of the oropharyngeal region and/orhypopharyngeal region, may vary between patients. Therefore, preferablythe apparatus 10 is available in a range of radial forces and sizes inorder to suit different individuals. Preferably, each of the embodimentsof the apparatus in accordance with the present invention are made ofresilient and elastic biocompatible materials and all edges and surfacesare smooth and free of sharp portions, burrs and contaminants.

[0084] FIGS. 2-6 show various embodiments of the invention that aregenerally cylindrical or tubular in structure. Except as expresslydescribed herein, each of the apparatus 10 a, 10 b, 10 c, 10 d and 10 e,shown in FIGS. 2-6 respectively, is similar to apparatus 10 and isstructured, unless otherwise noted herein, to be utilized for thetreatment of sleep apnea and/or snoring as hereinabove noted.

[0085] Turning now specifically to FIG. 2, apparatus 10 a is structuredto fit substantially entirely within the oropharyngeal region and atleast partially within the valecullar space and/or preferably extendingno higher than the upper surface of the base of the tongue in theanterior portion of the apparatus. The posterior portion of theapparatus may be designed to provide additional support above theoropharyngeal region.

[0086] The appliance 12 defines a central open or hollow space 12 a andcan be made of any suitable biocompatible material, for example,stainless steel, other metals, or plastics (polymeric materials), andthe like, and combinations thereof.

[0087]FIG. 3 shows an apparatus 10 b in accordance with the presentinvention comprising a substantially cylindrical appliance 14 similar toappliance 12, with the most significant difference being that appliance14 is comprised of a mesh, for example a woven wire mesh. The meshappliance 14 defines a central open or hollow space 14 a and preferablycomprises wires 14 b made of a super-elastic material, for example, anickel titanium alloy (to be described in more detail elsewhere herein),such as the alloy known as Nitinol.

[0088]FIG. 4 shows an additional apparatus 10 c of the presentinvention, similar to apparatus 10 a, comprising a solid cylindricalappliance 16 including a feature of a cut-out region 17 defined in theappliance 16, the cut-out region being appropriately sized, shaped, andpositioned to accommodate natural movements and functions of theepiglottis of the patient. Thus, in this embodiment of the invention,apparatus 10 c is fitted to a patient with cut-out portion 17 facing ananterior wall of the oropharyngeal region. The epiglottis is thereforefree to move inwardly and outwardly of the appliance by means of thecut-out region.

[0089]FIG. 5 shows yet another apparatus 10 d of the present invention,comprising an appliance 18 having a relatively wider diameter distal orlower portion 19 which functions to anchor or hold the appliance 18within the valecullar space. When in use, apparatus 10 d is anchored atportion 19 within the vallecular space allowing the epiglottis tofunction normally within the relatively wider hollow area defined by thelower portion 19.

[0090]FIG. 6 shows a further embodiment of the invention, specificallyan apparatus 10 e generally comprising an appliance 20 having a helicalor spiral spring including coils 22 comprising, for example, asuper-elastic material, as described elsewhere herein.

[0091] FIGS. 7-11 show various other embodiments of the invention thatare generally non-circumferential in structure. Except as expresslydescribed herein, each of the apparatus 10 f, 10 g, 10 h, 10 i and 10 j,shown in FIGS. 7-11 respectively, is similar to apparatus 10 and isstructured, unless otherwise noted herein, to be utilized for thetreatment of sleep apnea and/or snoring as herein noted.

[0092] Turning now specifically to FIG. 7, the present inventionpreferably provides apparatus 10 f, comprising an appliance 26 that isnon-circumferential in structure. In other words, apparatus 10 f, unlikeapparatus 10 a-10 e, includes spaced apart end portions 27 defining agap 32, and a closed portion 34. The end portions 27 are preferablyrounded as shown.

[0093] More specifically, the appliance 26 may be described ascomprising a substantially C-shaped member 35 defining a pair ofresilient, flexible wire struts 36 a and 36 b connected at the endportions 27. The struts 36 a and 36 b may have any suitable transversecross-section, for example, a circular, oval, rounded, flattened or thelike transverse cross-section. In this particular embodiment of theinvention, the member 35 comprises a wire or ribbon that forms acontinuous loop as shown, defining an open interior space 38.

[0094] Still referring to FIG. 7, the appliance 26 is structured to bepositioned within the oropharyngeal region with the end portions 27bearing against and providing an opening force against the lateral wallsof the oropharyngeal region. It is contemplated that the apparatus 10 fmay be alternatively positioned such that the appliance 34 restssubstantially within or entirely within the valecullar space and pressesagainst the base of the tongue along closed portion 34.

[0095] Upon contraction of the oropharyngeal region, for example, duringswallowing, the end portions 27 will be temporarily forced toward oneanother by the muscles in the oropharyngeal region, and may or may notoverlap or contact one another. The flexibility and relative spacing ofthe struts 36 a and 36 b allow the appliance 34 to contract and expandin the vertical direction as necessary, for example in conjunction withperistalsis of the pharyngeal walls upon swallowing.

[0096] Preferably, each of the embodiments of the present invention iscomprised of highly elastic, biocompatible materials. In particular,each of the non-circumferential apparatus in accordance with the presentinvention preferably comprises a super-elastic material, morepreferably, a nickel titanium (NiTi) alloy, such as the alloy known asNitinol.

[0097] For general background purposes, a description of the benefits ofNitinol for use in the present invention follows. Additional details ofthis alloy can be obtained from readily available sources and/or will beknown to those of skill in the art.

[0098] Nickel titanium (also known as Nitinol) is in the class ofmaterials known as shape memory alloys. A thermoelastic martensiticphase transformation in the material is responsible for itsextraordinary properties. These properties include the shape memoryeffect, super-elasticity, and high damping capability.

[0099] Nitinol has the ability to absorb large amounts of strain energyand release it as the applied strain is removed. Nitinol also hasexcellent torqueability and kink resistance, which is an importantfeature of the apparatus of the present invention due to the dynamicnature of the oropharyngeal and hypopharyngeal regions. Advantageously,super-elastic Nitinol alloys provide a substantially constant force overa large strain range.

[0100] The present apparatus more preferably comprise a Nitinolmaterial, more preferably with a ratio of the two constituents, nickeland titanium, at about 50 atomic percent each (about 55 percent byweight of nickel).

[0101] The properties of Nitinol can be modified by changes in alloycomposition, mechanical working, and heat treatment, as known to thoseof ordinary skill in the art. The specific alloy used in the apparatusof the present invention is selected mainly for its super-elastic effectrather than its shape memory effect.

[0102] Super-elastic Nitinol alloys preferably are used in the apparatusof the present invention to take advantage of a stress-inducedmartensitic transformation in order to achieve extreme amounts offlexibility and kink resistance. It is known that an alloy of nickel andtitanium can behave super-elastically if its Active A_(f) temperature isjust below the use temperature. For example, alloys which are intendedto be super-elastic at room temperature are generally produced withtheir Active A_(f) temperatures just below room temperature in the rangeof about 0 to about 20° C. A super-elastic material will not besuper-elastic at all temperatures, but will exhibit good super-elasticproperties in a temperature window extending from the Active A_(f)temperature up to a temperature which is about 50° C. above ActiveA_(f). Therefore, a material with an Active A_(f) of about 15° C. willexhibits good super-elasticity up to about 65° C. which means that thematerial will exhibit good super-elasticity at both room temperature andbody temperature (37° C.)

[0103] Nitinol is the more preferred material for the apparatus of thepresent invention also due to its excellent biocompatibility, very highcorrosion resistance, and excellent cytocompatibility. In addition, thenickel in nickel/titanium alloy is chemically joined to the titanium ina strong intermetallic bond, so the risk of reaction, even in patientswith nickel sensitivity, is extremely low. Additional details on nickeltitanium alloys are known to those of ordinary skill in the art and areprovided, for example, in Jervis, U.S. Pat. No. 6,306,141, which isincorporated herein in its entirety by this specific reference.

[0104] FIGS. 8-10 show alternative embodiments of the invention similarto the embodiment shown in FIG. 7 in that the appliance isnon-circumferential as defined elsewhere herein.

[0105] More specifically, referring to FIG. 8, an apparatus 10 g inaccordance with the invention is shown that generally comprises acuff-shaped appliance 50. Like appliance 26, appliance 50 includesspaced apart end portions 27 g defining a gap 32 g, and closed portion34 g. A substantial distinction between apparatus 10 g and apparatus 10f is that apparatus 10 g comprises relatively wide, opposing outerperipheral portions 56 a and 56 b, that define flattened bands, ratherthan struts 36 a and 36 b. The outer peripheral portions 56 a and 56 bdefine an open interior space 58. Relative to apparatus 10 f, thisparticular design generally allows greater surface contact withoropharyngeal tissues as well as greater hoop strength or openingpressure.

[0106]FIG. 9 shows an apparatus 10 h of the invention comprising acuff-shaped appliance 60 similar to appliance 50 for accommodating apatient with different needs, for example, a patient having a longer,more narrow oropharyngeal region. Appliance 60 includes spaced apart endportions 27 h defining a gap 32 h and closed portion 34 h.

[0107]FIG. 10 shows another apparatus 10 i in accordance with theinvention, the apparatus 10 i being similar to the embodiment shown inFIG. 8. A significant distinction between apparatus 10 i and apparatus10 g is that the apparatus 10 i comprises a substantially mesh structurefor providing increased flexibility and/or to facilitate tissue ingrowthto restrict or prevent migration of the apparatus 10 i. For example, theappliance 64 comprises an outer peripheral portion 66 made of a wovenmesh wire for example, defining an interior space 68.

[0108]FIG. 11 shows yet another apparatus 10 j in accordance with thepresent invention, comprising a non-circumferential cuff-shapedappliance 82 having spaced apart end portions 27 j defining a gap 32 j.A significant distinction between apparatus 10 j and apparatus 10 g isthat appliance 82 does not include interior space 58, but is insteadsubstantially solid as shown. In addition, appliance 82 preferablyincludes one or more through apertures 87 for facilitating tissueingrowth.

[0109] FIGS. 12-21 show various embodiments of the invention that aregenerally planar when in a resting or non-deployed state, for example,when the apparatus is located outside of the oropharyngeal region of apatient in a rest position. Except as expressly described herein, eachof the apparatus 10 k, 10 m, 10 n, 10 p and 10 q, 10 s, 10 t, 10 u, 10 vand 10 w shown in FIGS. 12-21 respectively, is similar to apparatus 10and is structured, unless otherwise noted herein, to be utilized for thetreatment of sleep apnea and/or snoring as herein noted.

[0110] Turning now to FIG. 12, apparatus 10 k, in accordance with thepresent invention, generally comprises an appliance 110 having a flat,or substantially planar configuration (represented by phantom lines)that is flexible to achieve an arched, or curved configuration (shown insolid line). Like the embodiments of the invention shown in FIGS. 7-11,the apparatus 10 k defines a non-circumferential configuration when inthe deployed state.

[0111] More particularly, the appliance 110 comprises a body portion 112and end portions 114 spaced apart by the body portion 112. The appliance110 may be in any suitable form, such as, for example, a substantiallyrectangular (shown in FIG. 12), a substantially circular form, asubstantially oblong form, a substantially oval form or a substantiallyelliptical form or the like configuration. When located in theoropharyngeal region, the appliance 110 is structured to exert asufficient force, more preferably a sufficient substantially constantradial force, on the oropharyngeal region, particularly against thelateral walls of the oropharyngeal region, to maintain or cause theairway passing through the region to be patent, so that it issubstantially open or unobstructed.

[0112] The appliance 110 is structured to take on a deployedconfiguration when located within the oropharyngeal region such that theend portions 114 are spaced apart from each other by other than the bodyportion 112. For example, the end portions 114 may be spaced apart bythe epiglottis or a portion of the anterior or posterior wall of theoropharyngeal region. The apparatus 110 is structured to be sufficientlyresilient and flexible to allow for normal dynamic movement or motion ofthe oropharyngeal region with little or no loss in desirable properties,such as hoop strength and the like, over an extended period of wear.

[0113] Advantageously, the apparatus 10 k may be formed entirely from aunitary flat sheet of material that is laser cut into the desiredconfiguration. Using a flat elastic or super-elastic sheet of materialor a sheet pre-curved to a diameter larger than that of theoropharyngeal region of the human or animal, the apparatus 10 k, onceimplanted into the oropharyngeal region, applies substantiallycontinuous opening pressure to the oropharyngeal walls, for example, thelateral walls of the oropharyngeal region.

[0114] Appliance 110 may have a length of between about 50 mm and about90 mm in the substantially flat configuration, and a height of betweenabout 15 mm and about 25 mm. The dimensions of appliance 110 areselected based on individual patient need. The appliance is designedsuch that the effective non-constrained diameter of the appliance, whendeployed, is greater than about 32 mm.

[0115] Appliance 110 comprises a plurality of flexible wire or ribbonstruts 140, which preferably extend between the radiused end portions114 extending along a substantial portion of the length of the appliance110. For example, the appliance 110 may comprise between about 2 andabout 50 struts or more, and preferably between about 6 and about 20struts, such as about 10 struts.

[0116] In the embodiment shown in FIG. 12, each of the struts 140 has athickness of about 0.005 inch and a width of about 0.010 inch. Thisdesign has been found to provide the required flexibility and resiliencyin at least three dimensions or directions of motion, and preferably, inaddition, twisting motion, without exhibiting significant fatigue overan extended period of wear/time in service requiring dynamic movement,such as in the oropharyngeal region.

[0117] The number, thickness, and width of the struts 140 may be variedto produce a desired opening pressure (e.g., hoop strength) on the baseof the tongue or to reduce or increase the surface area of the struts140 which are in contact with the oropharyngeal walls. This design alsoallows improved vertical collapse/deformation of the oropharyngealregion, for example, allowing peristalsis type movement duringswallowing.

[0118] When provided in an oropharyngeal region of a patient for thetreatment of sleep apnea and/or snoring, the appliance 110 is curvedwith a convex surface pressing against the tissues to be supported,particularly the lateral walls of the oropharyngeal region and/or thebase of the tongue.

[0119] The appliance 110 is structured to be self-expanding with acontrolled length during such expansion. This can be achieved bysuitable selection of super-elastic materials, preferably Nitinol, andappropriate selection of strut length and other dimensions. Theappliance 110 also is preferably structured to have a relativelyatraumatic nature of all surfaces thereof and of the curved endportions. In addition, the appliance 110 is structured to exhibit theability to be delivered in a minimal diameter access manner by rollingthe appliance 110 onto itself within a catheter, inserter tube and thelike.

[0120] The appliance 110 may be tailored to be effective in a variety ofpatients and in a variety of different body regions that would benefitfrom the consistent support provided by such an appliance. For example,the size and structure of the appliance can be selected to accommodate aspecific need. The amount of force provided by the appliance can bemodified by appropriate selection of the number of struts, width and/orthickness of struts, and/or surface area covered by the struts and/orthe like factors. Generally, as the struts become thinner and take upless surface area, the appliance 110 will become more compliant and willmove and flex with less radial force exerted thereby and will flex to agreater extent without permanent deformation. It is noted that a portionof appliance 110 may be modified such that it will function to anchor orsecure the appliance in place. For example, an outer or peripheral strut140 a may be configured to achieve a “fluted” configuration. In someembodiments, although not shown, one or more of the struts may be shapedas wave forms or s-shapes. In yet other embodiments, although not shown,cushioned end members may be provided on the end portions 114 of theappliance 110 in order to enhance comfort and/or proper fit.

[0121] An optional feature of the invention is shown at 141 forfacilitating anchoring of the apparatus 10 k in the given position. Morespecifically, at least one of the struts 140 b may be configured to formbarbed portions 145 a and 145 b for enhancing secure attachment of theappliance 110 to the posterior wall of the oropharyngeal region. It isalso contemplated that other means for securing the apparatus 10 k inthe given position may be provided, for example, surfaces of theapparatus 10 k may be coated with a biologically compatible glue oradhesive.

[0122]FIG. 13 shows another apparatus 10 m including appliance 210 fortreating sleep apnea and/or snoring, in accordance with the presentinvention. Apparatus 10 m is similar to apparatus 10 k, with anadditional feature shown on apparatus 10 m being the addition of spacingportions 242, positioned and structured to maintain a spaced apartrelationship between adjacent struts 240 when apparatus 10 is in theoropharyngeal region of a patient. Appliance 210 includes end portions214 and body portion 212.

[0123]FIGS. 14 and 15 show apparatus 10 n and 10 p respectively, fortreating sleep apnea and/or snoring, in accordance with the presentinvention. Apparatus 10 n and apparatus 10 p are similar to apparatus 10k and 10 m, with the most significant distinction being that apparatus10 n and 10 p are substantially oval or elliptical rather thanrectangular in shape. Apparatus 10 n generally comprises appliance 310including rounded end portions 314 joined by body portion 312, and aplurality of spaced apart struts 340. Apparatus 10 p generally comprisesappliance 410 including rounded end portions 414 joined by body portion412, and a plurality of spaced apart struts 440 and spacing portions442.

[0124]FIG. 16 shows yet another apparatus 10 q for treating sleep apneaand/or snoring in accordance with the present invention. As shown,apparatus 10 q comprises an appliance 510 having a substantiallyelliptical shape and including a plurality of bowed or arched struts 545that converge at end portions 514.

[0125] Turning now specifically to FIGS. 17-21, additional alternativeembodiments of the present invention are shown. Like the embodiments ofthe invention shown in FIGS. 12-16, these embodiments are typicallyplanar in structure when at rest and not deployed in the oropharyngealregion of a patient. A significant distinction between the embodimentsshown in FIGS. 12-16 and the alternative embodiments shown in FIGS.17-21, is that the latter embodiments each preferably define a singlecontinuous loop.

[0126] More specifically, FIG. 17 shows an apparatus 10 s for treatingsleep apnea and/or snoring in accordance with the present invention,comprising a substantially cross-shaped appliance 610, defined by asingle loop element 612. The appliance 610 preferably is cut, morepreferably photoetched, from a single sheet of material, preferably asheet comprising a Nitinol superelastic alloy material, and preferablyhaving a sheet thickness of about 0.01 inch to about 0.1 inch. Element612 preferably has a substantially uniform width of between about 1 mmto about 5 mm or greater. The appliance 610 preferably has a height Halong a vertical axis of about 15 mm to about 25 mm, and a length Lalong a horizontal axis of about 60 mm to about 90 mm allowing aneffective non-constrained diameter of greater than about 32 mm. Thecross-shaped appliance 610 preferably is symmetrical about its verticaland horizontal axes. Appliance 610 includes vertical portions 616 a and616 b each defining an angle α, and horizontal portions 618 a and 618 beach defining an angle β.

[0127] For purposes of example only, not to be considered limiting thescope of the present invention, vertical portions 616 a and 616 b definea peak-to-peak measurement (i.e. height H) of about 25 mm, andhorizontal portions 618 a and 618 b define a peak-to-peak measurement(i.e. length L) of about 70 mm. Also for purposes of this specificexample only, each of vertical portions 616 a and 616 b defines an angleα of about 150 and each of horizontal portions 618 a and 618 b definesan angle β of about 6°.

[0128] Appliance 610 is structured to be placed in the oropharyngealregion in a position such that horizontal portions 618 a and 618 b restagainst and provide support to the lateral walls of the oropharyngealregion. The vertical axis of the apparatus 610, generally defined byvertical portions 616 a and 616 b, are disposed against or adjacent theposterior wall of the oropharyngeal region.

[0129]FIG. 18 shows yet another apparatus 10 t for treating sleep apneaand/or snoring in accordance with the present invention. Apparatus 10 tis similar to apparatus 10 s in that it is defined by a single loopelement 712 cut from a single sheet of material, for example, a Nitinolalloy. A substantial distinction between apparatus 10 s and apparatus 10t is that, rather than comprising a cross-shaped appliance 610,apparatus 10 t comprises a substantially X-shaped appliance 710 having alength L and a height H. Appliance 710 includes multiple leg portions717 a, 717 b, 717 c and 717 d extending from a generally central region720, wherein paired leg portions 717 a and 717 c and paired leg portions717 b and 717 d, both define an angle φ.

[0130] For purposes of this specific example only, not to be consideredlimiting the scope of the present invention, appliance 710 has a lengthL of about 70 mm and a height H of about 25 mm, and angle φ is about36°.

[0131] Appliance 710 is structured to be placed in the oropharyngealregion in a position such that leg portions 717 a, 717 b, 717 c and 717d rest against and provide support to the lateral walls of theoropharyngeal region, and the generally central portion 720 is disposedagainst or adjacent the posterior wall of the oropharyngeal region.

[0132]FIG. 19 shows yet another apparatus 10 u for treating sleep apneaand/or snoring in accordance with the present invention. Apparatus 10 uis similar to apparatus 10 s in that it is defined by a single loopelement 812 cut from a single sheet of material, for example, a Nitinolalloy. Apparatus 10 u comprises an appliance 810 having a relativelynarrow, generally central body portion 814 (having height H₁)terminating at relatively wide end portions 816 a and 816 b (havingheight H₂), and a length L. End portions 816 a and 816 b preferablydefine angle γ as shown.

[0133] For purposes of this specific example only, not to be consideredlimiting the scope of the present invention, appliance 810 has a lengthL of about 85 mm, a height H₁ of about 10 mm, a height H₂ of about 35mm, and an angle γ of about 75°. Element 812 has a width W₁ at generallycentral portion 814 and a width W₂ of about 5 mm at end portions 816 aand 816 b.

[0134] Appliance 810 is structured to be placed in the oropharyngealregion in a position such that end portions 816 a and 816 b rest againstand provide support to the lateral walls of the oropharyngeal region,and the generally central body portion 814 is disposed against oradjacent the posterior wall of the oropharyngeal region.

[0135]FIG. 20 shows yet another apparatus 10 v for treating sleep apneaand/or snoring in accordance with the present invention. Apparatus 10 vcomprises an appliance 910 comprising loop element 912, and including agenerally central body portion 914, and multiple end portions 916 a, 916b, 916 c and 916 d. As shown adjacent end portions define an angle η.Appliance 910 further includes a vertical portion 950 that defines anangle δ.

[0136] Appliance 910 is structured to be placed in the oropharyngealregion in a position such that multiple end portions 916 a, 916 b, 916 cand 916 d rest against and provide support to the lateral walls of theoropharyngeal region, and the generally central body portion 914 isdisposed against or adjacent the posterior wall of the oropharyngealregion.

[0137]FIG. 21 shows yet another apparatus 10 w for treating sleep apneaand/or snoring in accordance with the present invention. Apparatus 10 wcomprises an appliance 1010 that is somewhat similar to appliance 910 inthat appliance 1010 includes a generally central body portion 1014 andmultiple end portions 1016 a, 1016 b, 1016 c and 1016 d. Appliance 1010has somewhat different proportions, including a relatively wide uppercentral portion 1019 that is configured to provide enhanced tissuesupport to portions of the posterior wall of the oropharyngeal region,relative to tissue support provided by appliance 910.

[0138] FIGS. 22-23 show other embodiments of the invention for treatingsleep apnea and/or snoring. Like the embodiments of the invention shownin FIGS. 12-22, these embodiments are typically planar in structure whenat rest and not deployed in the oropharyngeal region of a patient.

[0139]FIG. 22 shows an apparatus 10 x in accordance with the inventioncomprising a substantially symmetrical appliance 1110 including asubstantially linear body portion 1112 and a plurality of struts 1118extending from the body portion 1112, for providing support to theoropharyngeal tissues. The number and length of struts 1118 preferablyare selected based on a particular patient need. For purposes of exampleonly, appliance 1110 may have an upper portion 1120 having about twopairs of struts 1118 defining a tip to tip length L₁ of about 62 mm, anda lower portion 1122 having about five pairs of struts 1118 defining atip to tip length L₂ of about 82 mm.

[0140]FIG. 23 shows an apparatus 10 y in accordance with the inventionthat is similar to apparatus 10 x. The most significant distinction isthat apparatus 10 y comprises an appliance 1210 that includes a bodyportion 1212 and struts 1218 that are offset from one another along bodyportion 1212.

[0141] Turning now to FIG. 24, a preferred embodiment of the inventionis shown, generally at 10 z. Apparatus 10 z is similar to apparatus 10 athrough apparatus 10 x in that apparatus 10 z is structured to beeffective in maintaining patency of the airway of a patient 1, forexample, the oropharyngeal region 1 a of a patient. However, apparatus10 z is specifically structured to be at least partially, and in somecases substantially entirely submucosally, implantable into thepharyngeal region, for example the oropharyngeal region, of the patient.

[0142] Apparatus 10 z, more clearly shown in FIG. 25, preferablycomprises a single elongated element 1401 having end portions, forexample, rounded end portions 1406 and a body portion 1408 extending orconnected therebetween.

[0143] As shown, end portions 1406 are preferably structured tofacilitate implantation, for example, surgical implantation, of theelement 1401. For example, end portions 1406 may include appropriatelysized apertures 1410 for receiving suturing thread. The element 1401 mayhave a rounded cross-section such as shown in FIG. 25a, or a polygonalcross section, for example a rectangular cross section, such as shown inFIG. 25b.

[0144] Referring still to FIG. 25, element 1401 preferably has a lengthL of between about 50 mm and about 70 mm and a width W of between about2 mm or less and about 6 mm. Dimensions of the appliance 1400 may be atleast in part based upon, for example, the size or diameter of thepatient's pharyngeal region and the specific portion of the pharyngealregion to be supported by the apparatus 10 z. A typical area of supportas mentioned elsewhere herein, is the area encompassing, at least, aportion of one or more of the lateral walls of the oropharyngeal region.

[0145] Appliance 1400 preferably comprises Nitinol, Dacron®, or othersuitable, flexible, elastic biocompatible material as discussedelsewhere herein.

[0146] Advantageously, the element 1401 is designed to be surgicallyimplantable in the pharyngeal region, at least partially circumscribingthe region, and at least partially, preferably substantially entirely,beneath the mucosal layer thereof. The appliance 1400 may also be atleast partially sutured to the pharyngeal tissues, for example, at endportions 1401 a of the element 1401, and/or secured to the oropharyngealtissues by means of a biocompatible adhesive.

[0147] Turning now to FIG. 26, appliance 1400 is shown sized to beplaced at least partially circumscribing an interior hollow passage(representing a cross-section of the airway of the patient) defining thepharyngeal region. This view (as well as views shown in FIG. 27 and FIG.28) is a simplified representation of a cross-section of theoropharyngeal region 1 a, with posterior wall 2 d and anterior wall 2 g,(which includes the base 2 f of the tongue 2 a) and opposing right andleft lateral walls 2 b. This placement of appliance 1400 is effective inproviding support to the lateral walls 2 b of the oropharyngeal region 1a. The appliance 1400 is shown substantially entirely submucosallyimplanted.

[0148] Turning now to FIG. 27, appliance 1400 is shown sized to beplaced circumscribing, at least one full circumference of, the interiorhollow space defined by the pharyngeal region. In this case, theappliance 1400 is sized to traverse the base 2 f of the tongue 2 a, forexample, beneath the mucosal tissue thereof. The appliance 1400 is shownpartially submucosally implanted.

[0149]FIG. 24a shows another apparatus, generally at 10 za, inaccordance with the present invention. Apparatus 10 za is substantiallysimilar to apparatus 10 z, except that apparatus 10 za comprises anappliance 1400 a including a plurality of elongated, spaced apartelements, for example at least two, or three or even more spaced apartelements 1401 a, 1401 b, and 1401 c, depending upon the specific needsof a particular patient. Except as indicated elsewhere herein, it is tobe appreciated that elements 1401 a, 1401 b and 1401 c are structured tobe placed, for example, at least partially submucosally, implanted in amanner as described hereinabove with respect to element 1401.

[0150] Each element 1401 a, 1401 b, and 1401 c may be substantially,entirely independent, or unitary, in structure with respect to eachother element 1401 a, 1401 b, and 1401 c. Alternatively, the multipleelements 1401 a, 1401 b, and 1401 c may be secured to each other bysuitable means, for example, suturing, wire, ribbon or the like, forsubstantially maintaining the spaced apart relationship between theelements 1401 a, 1401 b, 1401 c when the elements 1401 a, 1401 b, 1401 care positioned within and secured to the pharyngeal region.

[0151] In a related embodiment of the invention, a method is providedfor maintaining patency of a pharyngeal region. Particularly, the methodmay comprise the step of at least partially submucosally placing atleast one elongated element within the pharyngeal region, for examplethe oropharyngeal region in one or more strategic locations, wherein theplacement thereof will cause the region to be stiffened or strengthenedagainst collapse during natural sleep.

[0152] To illustrate another optional feature of the present invention,FIG. 28 shows a simplified view of the oropharyngeal region 1 a of apatient, having apparatus 10 zb in accordance with an embodiment of theinvention, submucosally implanted therein. Apparatus 10 zb comprises oneor more magnetic components 1500 a and 1500 b, structured and designedto be effective to provide a magnetic field useful for providing gentle,substantially constant and continuous resistance against collapse of thepharyngeal walls, particularly the lateral walls 2 b of theoropharyngeal region 1 a, for example during natural sleep, whileallowing substantially normal functioning of the pharyngeal region, forexample during swallowing.

[0153] In the example shown, the two magnetic components 1500 a, 1500 bare strategically placed within the oropharyngeal region 1 a such thatlike magnetic poles (i.e. repellant magnetic poles) are positionedsubstantially facing one another to create a magnetically repellantforce therebetween (indicated in simplified form by arrows 1502). Therepellant force caused by the strategically placed magnetic components1500 a and 1500 b is effective for providing an opening force within theoropharyngeal region, thereby maintaining patency of the region duringnatural sleep while still allowing constriction of the region duringswallowing.

[0154] It will be appreciated by those of skill in the art that not allpossible variations of the apparatus for treating sleep apnea and/orsnoring are shown, and that there are many other variations of theapparatus that are structured and shaped to provide specific support todifferent areas of the pharyngeal region, for example, the oropharyngealregion in order to treat sleep apnea and/or snoring, and based on thespecific needs of a particular patient. Each of these variations isconsidered to be within the scope of the present invention.

[0155] In yet another broad aspect of the present invention, methods areprovided for maintaining patency of a pharyngeal region, for example,the oropharyngeal region, in order to substantially reduce theoccurrence of sleep apnea and/or snoring. These methods in accordancewith the invention comprise, for example, steps of strengthening,reinforcing and/or stiffening tissues of the region which are subject tocollapse during natural sleep. For example, this may be accomplished byany one or more of the following steps: injecting an agent into thetissues which will cause partial necrosis of portions of the tissues inthe region, thereby stiffening the region; injecting, into the tissues,a liquid or gel agent that solidifies within the region to provide areinforcement against collapse of the region; mechanically or chemicallyirritating the tissues to cause a tissue reaction that firms the tissuesof the region; and applying a wave energy to the tissues to cause atissue reaction that firms the tissues of the region, for example, butnot limited to ultrasonic energy, radiofrequency energy, thermal energy(either adding thermal energy to the tissues or chilling the tissue byremoving thermal energy). Combinations of two or more of these steps maybe advantageously employed.

[0156] A preferred method for maintaining patency of a pharyngealregion, in accordance with the present invention, generally comprisesproviding a member, for example elongated element 1401, in asubstantially flat or precurved configuration. The member has a bodyportion and end portions spaced apart by the body portion. The member isimplanted, at least partially submucosally, within the pharyngealregion, preferably the oropharyngeal region, such that the member iseffective to provide a substantially constant force against at least aportion of each of the lateral walls of the region.

[0157] Preferably, the step of implanting comprises implanting themember into the pharyngeal region such that the member is substantiallyentirely submucosally implanted in the pharyngeal region.

[0158] For example, the member may be implanted into oropharyngealtissues, preferably directly beneath the mucosal layer, by using acurved surgical needle to weave the member into and beneath thesubmucosal tissue.

[0159] In another embodiment of the invention, the method comprises thesteps of providing an apparatus in the oropharyngeal region of the humanor animal, for purposes other than surgery. The apparatus is effectivein treating sleep apnea and/or snoring and/or in maintaining patency ofthe oropharyngeal region during natural sleep of the human or animal,without causing substantial interference with one or more naturalfunctions of the epiglottis.

[0160] Each of the apparatus for treating sleep apnea and/or snoringdescribed and shown elsewhere herein are suitable for use in the methodsof the present invention. It is to be appreciated, however, that theapparatus used for performing the methods of the invention may takeother forms as well. For example, it is contemplated herein that aconventional stent may be used in maintaining the airway in thepharyngeal region, for example, the oropharyngeal region in an openstate, and such use is considered to be within the scope of the methodsof the present invention. The apparatus used in the methods of presentinvention may be devices, for example but not limited to, a conventionalstent, sized and structured for placement in another region of the humanor animal other than the pharyngeal region, for example, theoropharyngeal region.

[0161] In another embodiment of the invention, a method for maintainingpatency of a pharyngeal region of a patient comprises the steps ofproviding an apparatus in a first configuration, for example a rolled,coiled, or otherwise deformed configuration; inserting the apparatusinto the oropharyngeal region, for example through the oral or nasalcavity of the patient while the apparatus is in a first configuration;and, thereafter, allowing the apparatus to reconfigure or expand to adeployed second configuration, for example a substantially cuff shaped,C-shaped, or other suitable deployed configuration, within theoropharyngeal region.

[0162] Any suitable deployment assembly useful for inserting theapparatus through the mouth or oral cavity, or nasal cavity of a patientand into the oropharyngeal region may be utilized in accordance with themethods of the present invention.

[0163] For example, a suitable deployment assembly includes an outertube (about 10 mm diameter) and inner tube (about 8 mm diameter)disposed within the outer tube. A retaining clip may be used to fix thetubes in place with respect to each other. The appliance, for example inrolled form, is provided within the outer tube at a distal portionthereof. Graspers, having a manually manipulable proximal portion may beprovided through the tubes for assisting in positioning or removal ofthe appliance.

[0164] During insertion through the mouth or oral cavity of the patient,the deployment assembly is advanced past the tongue of the patient untilthe inner diameter of the outer tube and the rolled appliance passesinto the oropharyngeal region. The retaining clip is then removed fromthe inner tube. The graspers may be used to facilitate repositioning ofthe appliance as necessary or desirable. The appliance is deployed byretraction of the outer tube. (The assembly/graspers may be used tolater remove the appliance if desired).

[0165] In a more specific, related embodiment of the invention, thefollowing method is provided. This method generally comprises the stepsof providing a flat or pre-curved member (for example, appliance 110,210, 310, 410, 510, 610, 710, 810 910, 1010, 1110 or 1120 shown in thedrawings), pulling end portions of the flat or pre-curved membertogether to form a folded member and holding or temporarily securing theend portions together by means of a grasper, clamp, hemostat, suture(for example, a bioresorbable suture), and/or suitable means fortemporarily holding the end portions together in contact with oneanother. The method further comprises the steps of placing the member inthe folded or pinched configuration, into the oropharyngeal region, forexample by way of the oral or nasal cavity of the patient, and releasingthe end portions, thereby allowing the member to expand radially withinthe oropharyngeal region to provide a substantially constant radialforce against the lateral walls of the oropharyngeal region and/or thebase of the tongue.

[0166] The method may further comprise the step of repositioning themember while the member is located within the oropharyngeal regionand/or the step of removing the member therefrom. This may beaccomplished by folding the member into a rolled or pinchedconfiguration and withdrawing the member from the body region.

EXAMPLE 1

[0167] A 40-year-old, 5-foot, 11 in., 350 lb male is referred by hisprimary care physician for evaluation of sleep disturbance. Heexperiences snoring with apneic pauses, and severe daytimehypersomnolence with narcolepsy, and has so for many years. Hisoccupation as a truck driver has been jeopardized by this behavior.Several years prior, he underwent uvulopalatoplasty (UPPP) andtonsillectomy, without any significant relief of his symptoms. Thepatient claims that the use of CPAP was attempted, but was unsuccessful.

[0168] A polysomnography is performed indicating a RespiratoryDisturbance Index (RDI) of 113.4 with severe desaturations, bradycardia,and complete absence of stage 3, stage 4, and REM sleep. CPAP therapywas titrated to 18 cm of water, but the patient's RDI remained elevatedat 60 with ongoing, severe desaturations.

[0169] Appliance 1400 having a length of about 70 mm and a width ofabout 1.0 mm and a thickness of about 0.0075 inches (about 0.2 mm), isselected by the physician for submucosal implantation.

[0170] Under general anesthesia, and using direct laryngoscopytechniques, the appliance is introduced into the submucosal tissuesbeginning in the right lateral pharyngeal region, particularly the rightlateral oropharyngeal region. The appliance is introduced submucosallyusing a curved surgical needle which is used to carefully pull theappliance into the tissues in a manner that causes the appliance to besubstantially concealed within the tissues, with little or no exposureof any portion of the appliance postsurgically.

[0171] The appliance is guided medially, and inferiorly, travelingaround the posterior oropharyngeal region and ultimately into thesubmucosal tissues of the tongue base. The tongue base is then traversedand the appliance is brought back along the right lateral oroopharyngealwall. The appliance thus makes at least one complete rotation around thepharynx. Careful microscopic examination of the pharyngeal tissuesreveals no areas of appliance exposure. Extubation proceeds withoutdifficulty, and the patient is closely observed overnight.

[0172] During the first week of recovery, the patient reports havingsome desire to cough out the device, throat pain, dysphagia, andhoarseness.

[0173] However, by the end of the first week, these symptoms arereported as minimal. Further, the patient indicates a significantreduction in effort, wheezing, and noise during daytime breathing. A CTScan is performed to confirm adequate device placement and integrity. Amodified barium swallow study is obtained at the end of the second week.This study indicates that the appliance is intact, allowing normalswallowing in the pharyngeal region and appears to be providingcircumferential support to the oropharyngeal region.

[0174] Polysomnography is repeated at two weeks, showing significantimprovements in oxygen saturations and RDI.

EXAMPLE 2

[0175] A 50 year old, 5 foot 4, 180 pound, female patient complains ofsevere hypersomnolence. It is additionally noted that the patient'sspouse has longed complained of the patient's substantial nightlysnoring and has witnessed pauses in the patient's breathing followed bygasping for air when she sleeps (believed to be apneic pauses).

[0176] Following clinical tests and evaluation of patient history, thepatient is diagnosed with severe sleep apnea.

[0177] An appliance 1400 is selected for implantation in the patient. Inthis example, the appliance 1400 is made of Nitinol and has a length ofabout 40 mm, a width of 1.25 mm and a thickness of about 0.5 mm.

[0178] Under general anesthesia, and using direct laryngoscopytechniques, the appliance is introduced into the submucosal tissuesbeginning in the right lateral oropharyngeal region. The appliance isthen guided medially, and inferiorly, traveling around the posteriororopharyngeal region and ultimately into the submucosal tissues of theleft lateral oropharynx. The appliance does not traverse the tongue. Theappliance thus makes about a 180 degree rotation around the oropharynx.

[0179] Careful microscopic examination of the oropharyngeal tissuesreveals no areas of appliance exposure. Extubation proceeds withoutdifficulty, and the patient is closely observed overnight.

[0180] Within two weeks, the patient reports feeling more energy duringthe daytime and alertness upon awakening. Her husband remarks that thepatient's snoring has substantially decreased and she does not seem tobe experiencing apneic pauses during the night.

[0181] While this invention has been described with respect to variousspecific examples and embodiments, it is to be understood that theinvention is not limited thereto and that it can be variously practicedwithin the scope of the following claims.

What is claimed is:
 1. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region and an epiglottis, the apparatus comprising: an appliance sized and structured to be placed in a given position in the oropharyngeal region, other than to facilitate a surgical procedure, and being effective in treating at least one of sleep apnea and snoring, the appliance being further effective, when so placed, to provide at least one additional benefit relative to a device sized and structured for placement in a position in a human or animal other than in the given position in the oropharyngeal region when the device is placed in the given position in the oropharyngeal region.
 2. The apparatus of claim 1 wherein the appliance is sized so that, when so placed in the given position in the oropharyngeal region, the appliance is located substantially entirely in the oropharyngeal region.
 3. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced compliance of the appliance with the functioning of at least one of the oropharyngeal region and the epiglottis.
 4. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced ability of the appliance to do at least one of provide support against collapse of the oropharyngeal region during sleep, and allow closure of an airway in the oropharyngeal region during swallowing.
 5. The apparatus of claim 1 wherein the at least one benefit comprises an enhanced ability of the appliance to be tolerated by the human or animal in the given position.
 6. The apparatus of claim 1 wherein the appliance has an effective non-constrained diameter of at least about 32 mm.
 7. The apparatus of claim 1 wherein the appliance comprises a member defining a substantially C-shaped configuration.
 8. The apparatus of claim 1 wherein the appliance, when located outside a human or animal, comprises a substantially flat member.
 9. The apparatus of claim 1 wherein the appliance is sized and structured to permit substantially natural movement of the epiglottis when the appliance is located in the given position in the oropharyngeal region of the human or animal.
 10. The apparatus of claim 1 wherein the appliance includes spaced apart, radiused end portions.
 11. The apparatus of claim 1 wherein the appliance includes end portions and is further sized and structured, when the appliance is located in the given position, to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions being spaced apart anteriorly of the posterior wall.
 12. The apparatus of claim 1 wherein the appliance comprises a member having a substantially elliptical configuration.
 13. The apparatus of claim 1 wherein the appliance comprises a super-elastic material.
 14. The apparatus of claim 1 wherein the appliance comprises Nitinol.
 15. The apparatus of claim 1 wherein the appliance includes spaced apart end portions and a length defined between the end portions, and the appliance comprises a plurality of struts extending along at least a substantial portion of the length.
 16. The apparatus of claim 1 wherein the appliance comprises a cuff-shaped member.
 17. The apparatus of claim 16 wherein the cuff-shaped member includes spaced apart end portions.
 18. The apparatus of claim 17 wherein the cuff-shaped member is sized and structured to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions spaced apart by a portion of an anterior wall of the oropharyngeal region.
 19. An apparatus for treating a human or animal having a pharyngeal region, the apparatus comprising: an appliance sized and structured to be placed, at least partially submucosally, within the pharyngeal region of the human or animal and to be effective, when so placed, to maintain patency of the pharyngeal region during natural sleep of the human or animal.
 20. The apparatus of claim 19 wherein the appliance is structured to be effective in treating at least one of sleep apnea and snoring.
 21. The apparatus of claim 19 wherein the appliance is structured to be effective in treating sleep apnea.
 22. The apparatus of claim 19 wherein the appliance is structured to be placed in an oropharyngeal region.
 23. The apparatus of claim 19 wherein the appliance is sized to be placed at least partially circumscribing an interior hollow passage defined by the pharyngeal region.
 24. The apparatus of claim 19 wherein the appliance is sized to be placed at least partially circumscribing an interior hollow passage defined by an oropharyngeal region.
 25. The apparatus of claim 19 wherein the appliance is sized to be placed circumscribing an interior hollow passage defined by the pharyngeal region.
 26. The apparatus of claim 19 wherein the appliance is sized to be placed circumscribing, at least once, an interior hollow passage defined by the pharyngeal region.
 27. The apparatus of claim 19 wherein the appliance comprises at least one elongated element.
 28. The apparatus of claim 19 wherein the appliance comprises a single elongated element.
 29. The apparatus of claim 19 wherein the appliance comprises at least one elongated element having a polygonal cross-section.
 30. The apparatus of claim 19 wherein the appliance comprises at least one elongated element having a rounded cross-section.
 31. The apparatus of claim 19 wherein the appliance is structured to be substantially entirely submucosally placed within the pharyngeal region.
 32. The apparatus of claim 19 wherein the pharyngeal region has right and left lateral walls, and the appliance is structured to be implanted, at least partially submucosally, within the pharyngeal region, such that the appliance at least partially traverses the right and left lateral walls.
 33. The apparatus of claim 19 wherein the pharyngeal region has right and left lateral walls, and the appliance is structured to be implanted, substantially entirely submucosally, within the pharyngeal region, such that the appliance at least partially traverses the right and left lateral walls.
 34. The apparatus of claim 19 wherein the appliance comprises a super-elastic material.
 35. The apparatus of claim 19 wherein the appliance comprises Nitinol.
 36. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region and an epiglottis, the apparatus comprising: an appliance sized and structured to be placed in a position in the oropharyngeal region in proximity to the epiglottis, other than to facilitate a surgical procedure, and to be effective in treating at least one of sleep apnea and snoring.
 37. The apparatus of claim 36 wherein the appliance is structured to be at least partially submucosally placed in the oropharyngeal region.
 38. The apparatus of claim 34 wherein the appliance is structured to be substantially entirely submucosally placed in the oropharyngeal region.
 39. The apparatus of claim 36 wherein the appliance includes a magnetic component.
 40. The apparatus of claim 36 wherein the appliance is structured to cause tissue stiffening when the appliance is placed in the position in the oropharyngeal region.
 41. The apparatus of claim 36 wherein the oropharyngeal region has lateral walls and the appliance is structured, when so placed in the position, to support lateral walls of the oropharyngeal region against collapse during natural sleep, and to allow closure of an airway in the oropharyngeal region during swallowing.
 42. The apparatus of claim 36 wherein the appliance comprises a member defining a substantially C-shaped configuration.
 43. The apparatus of claim 36 wherein the appliance, when located outside a human or animal, comprises a substantially flat member.
 44. The apparatus of claim 36 wherein the appliance is sized to permit substantially natural movement of the epiglottis when the apparatus is located in the position.
 45. The apparatus of claim 36 wherein the appliance includes spaced apart, radiused end portions.
 46. The apparatus of claim 36 wherein the appliance includes spaced apart end portions and is further sized and structured to be positioned against a portion of a posterior wall of the oropharyngeal region with the end portions spaced apart by a portion of an anterior wall of the oropharyngeal region.
 47. The apparatus of claim 36 wherein the appliance has a resiliency and flexibility to allow natural functioning of the oropharyngeal region during swallowing and a hoop strength effective to support the oropharyngeal region against collapse during natural sleep.
 48. The apparatus of claim 36 wherein the appliance comprises a super-elastic material.
 49. The apparatus of claim 36 wherein the appliance comprises Nitinol.
 50. An apparatus for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region including lateral walls and an epiglottis, the apparatus comprising: an appliance sized and structured to be placed in a position in the oropharyngeal region in proximity to the epiglottis, other than to facilitate a surgical procedure, and being effective in treating at least one of sleep apnea and snoring, the appliance being structured, when placed in the position in the oropharyngeal region, to support the lateral walls of the oropharyngeal region against collapse during the time the human or animal is naturally sleeping.
 51. The apparatus of claim 50 wherein the appliance is sized so that, when placed in the position in the oropharyngeal region, the appliance is located substantially entirely in the oropharyngeal region.
 52. A method for treating at least one of sleep apnea and snoring in a human or an animal having an oropharyngeal region, a valecullar space and an epiglottis, the method comprising: providing an appliance in the oropharyngeal region of the human or animal, the appliance located in the oropharyngeal region being effective in treating at least one of sleep apnea and snoring during natural sleep of the human or animal.
 53. The method of claim 52 wherein the appliance, when located in the oropharyngeal region, is effective in maintaining patency of the oropharyngeal region during natural sleep of the human or animal without causing substantial interference with at least one natural function of the epiglottis.
 54. The method of claim 52 wherein the step of providing includes inserting the appliance into the oropharyngeal region while the appliance is in a first configuration and allowing the appliance to reconfigure to a second configuration within or in proximity to the oropharyngeal region.
 55. The method of claim 50 wherein the step of providing includes inserting the appliance into the oropharyngeal region through a mouth of the person or animal.
 56. An apparatus for maintaining patency of a human or animal oropharyngeal region having lateral walls, in order to control at least one of sleep apnea and snoring, the apparatus comprising: an appliance comprising a body portion and end portions spaced apart by the body portion, the appliance being structured to take on a deployed configuration when located within the oropharyngeal region, such that the end portions are spaced apart from each other anteriorly of a posterior wall of the oropharyngeal region, and the appliance being further structured to exert a force on the lateral walls of the oropharyngeal region, when the appliance is in the deployed configuration within the oropharyngeal region, in order to cause the oropharyngeal region to be maintained substantially unobstructed.
 57. The apparatus of claim 56 wherein the end portions are coupled together only through the body portion.
 58. The apparatus of claim 56 wherein the appliance is structured to form a relatively flat configuration when the appliance is at rest outside the human or animal.
 59. A method for maintaining patency of a pharyngeal region of a human or an animal during natural sleep, the method comprising the steps of: providing a member in a substantially flat or precurved configuration, the member having a body portion and end portions spaced apart by the body portion; and implanting the member, at least partially submucosally, within the pharyngeal region.
 60. The method of claim 59 wherein the pharyngeal region has right and left lateral walls, and the member is effective to provide a substantially constant force against at least a portion of each of the right and left lateral walls.
 61. The method of claim 59 wherein the step of implanting comprises implanting the member into pharyngeal region such that the member is substantially entirely submucosally implanted in the pharyngeal region.
 62. A method for maintaining patency of a pharyngeal region of a human or an animal during natural sleep and for purposes other than surgery, the method comprising the steps of: causing a tissue reaction of a pharyngeal region of a human or animal patient, said tissue reaction being effective in at least one of strengthening and stiffening lateral walls of the pharyngeal region.
 63. The method of claim 62 wherein the step of causing a tissue reaction comprises applying an active agent to the lateral walls.
 64. The method of claim 62 wherein the step of causing a tissue reaction comprises placing at least one member into the lateral walls.
 65. A method for maintaining patency or causing to become patent, open or unobstructed, an pharyngeal region of a human or an animal during natural sleep and for purposes other than surgery, the method comprising the steps of: suturing portions of the pharyngeal region of a human or animal, said suturing being effective in at least one of strengthening and stiffening lateral walls of the pharyngeal region. 